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Displaying 1 - 15 of 2248 items.

Health alert or recall ABL800 Flex System
Radiometer has become aware of a potential issue with abl800 basic and abl8xx flex analyzers with software versions below v6.19 mr2 and configured to report cna+. We have received sporadic incidents of positive and negative…
RecallHealth product recall | 2022-05-24
Health alert or recall Poches A Sang Quadruple
Macopharma noticed, since the beginning of 2022, an increasing rate of failed leucodepletion results of devices containing lcrd2 filters, the frequency is currently between 0.0001%-0.08% depending on the customer, to breakages…
RecallHealth product recall | 2022-05-24
Health alert or recall Ks White Nitrile Medical Examination Gloves
After initiating testing by a third-party lab, it was discovered that the tested lots did not meet the astm d6319 standard for medical gloves. Initial testing was received on March 4, 2022 and communicated to the original manufacturer. Confirmatory third…
RecallHealth product recall | 2022-05-20
Health alert or recall JAMP-SENNA: Out of Specification
The total yeast and mold count is out of specification for the affected lots. 
RecallHealth product recall | 2022-05-19
Health alert or recall PMS-Montelukast: impurity
Presence of an unspecified impurity near the acceptable concentration limit in the affected lot.
RecallHealth product recall | 2022-05-19
Health alert or recall Centricity Radiology, Zero Footprint and Pacs Systems
GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed. Recall start date: May 5, 2022
RecallHealth product recall | 2022-05-16
Health alert or recall Argyle Safety Fistula Cannula With Anti-Reflux Valve
Potential for blood leak to occur with the anti-reflux valve upon treatment completion. Recall start date: May 5, 2022.
RecallHealth product recall | 2022-05-16
Health alert or recall SOCLEAN 2 AUTOMATED SUPPLEMENTAL PAP MAINTENANCE DEVICE
Labelling changes were issued for the Soclean 2 such as 1) running the Soclean 2 for a 12-minute cycle time duration obtains a 99.9% reduction of microorganisms, 2) Soclean 2 is not an automated pap disinfecting system but rather an automated…
RecallHealth product recall | 2022-05-16
Health alert or recall Carescape Central Station
The Carescape Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected. Recall start date: May 10,…
RecallHealth product recall | 2022-05-16
Health alert or recall Alinity Hs/Hq System
The purpose of this notification is to inform you of a product recall for Alinty Hq analyzer and Alinity Hs slide maker stainer module.  Abbott hematology identified that product information letter (pi-l) 1035-2020 issued for fa18jun2020, which…
RecallHealth product recall | 2022-05-16
Health alert or recall Belotero Lidocaine
The recall activities are being conducted due to several temperature excursions on inbound shipment to Canada.  According, to the assessment by the manufacturer, Anteis S.A, no data is available for Belotero products after repeated freezing and…
RecallHealth product recall | 2022-05-16
Health alert or recall Primus Anaesthetic Workstation
During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…
RecallHealth product recall | 2022-05-10
Health alert or recall Citadel Bed Frame System
Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…
RecallHealth product recall | 2022-05-10
Health alert or recall Bililux
During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…
RecallHealth product recall | 2022-05-10
Health alert or recall Advanced Relief Eye Drops: product safety
The complaint bottle contains Naphazolin HCl 0.013% and Glycern 0.26%. 
RecallHealth product recall | 2022-05-09
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